EP1390154A1

EP1390154A1 - Device for the spraying of fluids

Info

Publication number: EP1390154A1
Application number: EP02740288A
Authority: EP
Inventors: Klaus-Dieter Beller
Original assignee: Braunform GmbH
Current assignee: Braunform GmbH
Priority date: 2001-04-30
Filing date: 2002-04-24
Publication date: 2004-02-25
Anticipated expiration: 2022-04-24
Also published as: EP1390154B1; DE10121232A1; ES2232759T3; DE10121232C2; JP2004537346A; ATE281890T1; DE50201519D1; US20040135002A1; DK1390154T3; WO2002087777A1; PT1390154E; US7497390B2

Abstract

A device for spraying a liquid, wherein the liquid is contained in a container that, in an initial state, is a unitary closed container comprising a head to be broken off or sawed off for providing the removal opening, has a spraying device to be arranged on the removal opening of the container. The spraying device has a basic spraying unit and a connecting adapter for the container, wherein the connecting adapter is fixedly connected to the spraying unit. The connecting adapter has an annular seal that rests sealingly on the container. The connecting adapter is essentially cylindrical and has a lower peripheral end provided with the annular seal. A sleeve having an upper open end and a lower end is provided. The lower end of the sleeve has a bottom. The sleeve receives the container. The sleeve is connected with the upper open end to the connecting adapter.

Description

Device for spraying liquids

The invention relates to a device for spraying liquids according to the preamble of claim 1.

A particular field of application of the invention is the administration of active substances for the human or animal body, in particular those intended for an injection and present in a liquid in an ampoule. However, the spray device according to the invention is also suitable for spraying other liquids of the most general kind.

In the therapeutic field, pharmacological agents can be administered by injections. However, this is problematic in some of the cases, for example in patients who are afraid of syringes, which is particularly the case in children and elderly patients. There are also patients with poor vein conditions in whom an injection is difficult or impossible to put. Even in restless patients, especially children and the mentally altered, it is often not possible to give them an injection. Emergency patients can also be in a non-injectable state.

For this reason, in addition to the long-established nasal sprays (see, for example, LIST, Paul Heinz: Pharmaceutical Form, Stuttgart, WVGmbH, 1976, pp. 7 ff.), An alternative method for injection is proposed in US Pat. No. 6,131,567, according to which formulations are used as aerosol for drugs like insulin.

This creates an alternative to the usual mode of administration of active ingredients, which are intended for injection and are present in a liquid, for the human or animal body. The basic idea is a spray as a drug form for drug absorption. The pharmacological active ingredients are not supplied by injection, but the liquid is sprayed into the patient's mucous membrane in a nebulized form, for example into the throat or nose area. This spray is distributed over the mucous membrane and is absorbed by the body. The mucous membrane has a large surface area and good blood circulation and therefore represents an almost ideal absorption site for medicinal substances. Appropriate mechanical equipment enables this mucosal application of medicaments located in ampoules or bottles or capsules by means of a suitable spray unit. This enables effects that significantly increase the range of use of existing and future ampoule goods for various medical treatments.

The advantages are as follows: Cannula and syringe are no longer necessary

Increased safety of use by avoiding infections, needle injuries to the patient and doctor as well as bleeding at the injection site and no hematoma formation Easy access to the application site, even in an emergency the drugs are not subjected to the damaging acidic environment of the stomach (gastrointestinal breakdown) therapeutic drug concentrations can be different for different Drugs are reached much more quickly than the gastrointestinal absorption of the first-pass effect in the liver is avoided (metabolic breakdown), avoidance of oral medication can be avoided over time. The effect is more uniform. There is no risk of infection (AIDS, hepatitis) the usual ampoule product is available for sublingual, buccal and nasal therapy without new approval. Treatment of large populations (for example in the third world)

Suction filters for protecting a medium or active substance are disclosed in DE 196 10 457 A1 and piercing plugs (septum) in the removal opening in WO 95/00195 A1.

The invention is based on the object of providing an easy-to-use and safe system for spraying liquids.

The technical solution is characterized by the features in the characterizing part of claim 1.

This creates an easy-to-use and safe system for spraying liquids. The basic idea is to combine a special container made of glass or plastic for the liquid to be sprayed in the manner of an ampoule with a special spraying device. The spray device is placed on the container containing the liquid in order to spray the liquid in the container by means of this spray device. The container can - as stated - be an ampoule, as is usually used for injections. It is only necessary to break off the head of the ampoule and to place the spray device on the removal opening created thereby. Instead of the ampoule, one can be used accordingly trained bottle can be provided in which several dosing units are included. The spray device is placed airtight and liquid-tight directly on the removal opening of the container. The ring seal is used for this. In the case of ampoules, this ring seal decisively compensates for the breaking point, which is not always exactly regular. Absolute tightness is also achieved with other containers at all times, especially if the containers vary slightly in shape. A mechanical device is provided by means of the spraying device in order to spray the liquid to be applied onto the desired mucous membrane in a simple manner. This creates a system that is suitable for everyday use and allows the user to administer the contents of the ampoule without undue effort. This makes this system suitable for many injection areas. The mechanical device for the mucosal application of medicaments in ampoules by means of a pump spray unit consists of a pump, a spray head, an ampoule connector and an ampoule fixing unit. As already mentioned at the beginning, it can also be other liquids that are in the container.

According to the invention, the spray device is formed from two basic elements. The base element represents the basic spray device, i.e. a universal spraying device that can be used for a wide variety of container cracks. The individual adaptation to the respective container is carried out by a second element, namely the connection adapter. This is placed individually and tightly on the basic spray device. This connection adapter ensures a perfect connection to the respective container. The advantage of this system is that it is inexpensive because only a single basic spray device is required. The connection adapters, however, are easy to manufacture. Any container can be adapted with an appropriate range. The basic spray device can be a commercial product, but it can also be a special development. The basic spray device and the connection adapter can be firmly connected to one another. In the sense of greater flexibility, however, the two elements can also be exchangeable in order to use basic pump systems with different metering volumes, as described above.

In order to arrange the container, in particular the ampoule, on the spray device, a holder for the container can be arranged on the spray device. This creates an ampoule fixation which ensures that a fixed connection between the spray device and the container is ensured before and during application without the spray device detaching from the container, for example.

The general advantages are as follows: Maximum operational safety, easy to use

Dosing accuracy gentle on the product

Reduction of time and material costs

The development according to claim 2 describes three different types of sealing. In the variant with the shoulder, the ring seal rests on this shoulder from above. In the variant with the outer jacket surface, the ring seal lies on the outside of the actual jacket (i.e. below the shoulder) of the container, while in the last variant the ring seal dips into the removal opening.

As already mentioned above, according to the development in claim 3, the spray device is preferably a pump spray device. After pressing the actuation button downward, a negative pressure is generated in the spray head during the subsequent independent upward movement of the actuation button, which sucks the liquid in the container up through the riser pipe to the spray head. During the subsequent pushing down of the actuation button, the suction channel is closed and the previously aspirated liquid in the spray head is pressed out through the nozzle. The advantage of this system compared to a pump system using excess pressure in the container is that no airtight sealing of the spray head to the container is necessary. This creates a simple mechanical device for the technical implementation of the spray device. In addition, the dosing is easily reproducible thanks to the pump system. 0.01 ml / stroke to 0.2 ml / stroke can be used as dosing volumes. By using the pump spray device with a predetermined stroke volume, it is possible to apply appropriately defined doses of the appropriate agent as needed and desired. The number of pump strokes can also be set, i.e. be limited. Instead of conveying the liquid by means of a pump system, other conveying systems are also conceivable which serve the corresponding purpose and feed the liquid to the spray head.

The advantage of the further development according to claim 4 is a germ protection.

Basically, the container can be turned upside down. This eliminates the need for a riser pipe. The development according to claim 5, however, proposes the use of the aforementioned riser. As a result, the spray device is located at the top and can therefore be operated better. The development according to claim 6 has the advantage that the riser pipe can be adapted to the intended purpose of the respective ampoule length.

Instead of an ampoule, a container in the form of a storage bottle, which is closed with a piercing stopper, can also be used. In this case, the riser pipe has a piercing pin, by means of which the piercing plug can be pierced.

The development according to claim 8 has the advantage that impurities which can get into the liquid when or after opening the ampoule are filtered out.

A further development according to claim 9 represents a technically simple holder. The basic idea is that a web extending in the longitudinal direction of the container is arranged from the spraying device and serves as an ampoule guide. This bridge ensures parallel guidance for the ampoule and prevents it from tilting. The contact pressure can be guaranteed by spring play or guide sleeve or by hand. A flexible ampoule fixation with locking with variable length of the guide bar enables the use of all common ampoule sizes.

The development according to claim 10 has the advantage that the forceps-like gripping of the container keeps it securely.

The development according to claim 11 has the advantage that the non-circular cross-section always ensures a sufficient contact pressure of the clamping arms on the ampoule.

As an alternative to the holder described above, the spray head can also be fastened to the container by means of a screw closure or a bayonet closure. For example, it is conceivable that the conventional ampoules, vials or capsules are additionally provided with an external thread in the area of the withdrawal opening.

A further preferred embodiment of the holder proposes claim 13. The basic idea is to insert the container, in particular the ampoule with the broken head end, into the sleeve and then to attach or screw on the connection adapter from above until the ring seal comes into contact with the shoulder of the container. This creates a holder for the container, in which Before the container is safely and securely arranged on the spray device. With the attached or screwed connection adapter, a compact unit is also created together with the sleeve.

The development according to claim 14 proposes different types of connection between the sleeve and the connection adapter. In the case of a releasable latching, the system can be reused by removing the connection adapter from the sleeve after use. The detachable connection can be made, for example, by latching elements in the form of circumferential ribs. The non-detachable connection between the sleeve and the connection adapter is intended for single use. The non-releasability can be achieved by an appropriate design of the latching elements. Finally, a type of bayonet lock can also be provided for a detachable connection.

The development according to claim 15 has the advantage that the cylindrical design of the connection adapter and the corresponding cylindrical design of the sleeve ensure a relatively large contact area and thus secure fixation of the connection adapter within the sleeve. In particular, this makes it possible to use containers of different heights in one and the same system by appropriate length specifications on the one hand of the sleeve and on the other hand of the connection adapter. The ring seal at the lower end of the connection adapter is preferably a molded seal, so that the connection adapter and the ring seal form a one-piece structural unit. The material of the ring seal is a different material than the material of the connection adapter.

Another preferred further development proposes, according to claim 16, that a spray head can be interchangeably arranged on the spray device. The advantage of this interchangeable spray head is that all current and future adapters, such as pharynx adapters with and without beaks, nose adapters, etc. can be used as required.

Three exemplary embodiments of a device according to the invention are described below with reference to the drawings. In these shows:

Figure 1 shows a first embodiment before inserting an ampoule.

Fig. 2 shows the embodiment of Fig. 1 after inserting the ampoule; 3 shows a longitudinal section through the system in FIG. 2;

4 shows a longitudinal section through a second embodiment;

5a and 5b longitudinal sections through a third embodiment.

1 to 3 show a first embodiment, in FIG. 4 a second embodiment and in FIGS. 5a and 5b a third embodiment of a device for administering a medicament present in an ampoule.

The first embodiment of FIGS. 1 to 3 has a spray device 1. This consists of a base spray device 2 and a connection adapter 3. This connection adapter 3 is in particular attached to the base spray device 2 from below. Depending on the application, different forms of connection adapters 3 can be used.

A holder 4 is arranged on the connection adapter 3. This consists of a web 5 extending in the longitudinal direction. Two pairs of clamping arms 6 are arranged one above the other on this web.

The spray device 1, namely its base spray device 2, has a riser pipe 7 on the underside and a spray head 8 on the top. This is interchangeable and therefore adaptable to the respective application.

It works as follows:

The spray system is to be connected to a container 9 filled with a medicament in the form of an ampoule. For this purpose, the glass head of the container 9 is first broken off, as is indicated in FIG. 1. Subsequently, the container 9 is inserted from below along the web 5 of the holder 4 into the connection adapter 3 of the spray device 1. For this purpose, the riser pipe 7 projects into the removal opening 10 of the container 9. As can be seen in FIG. 3, the upper shoulder of the container 9 comes into sealing contact with an annular seal 11 inside the connection adapter 3. The container 9 is held in this position by the clamping arms 6. By actuating the pump spray head 8, the liquid in the container 9 can be sprayed. The second embodiment in FIG. 4 differs from the first embodiment in the type of arrangement of the container 9 in the connection adapter 3. While a holder 4 is provided in the first embodiment, this embodiment has no such holder. Here, the fixation is achieved directly between the connection adapter 3 and the upper region of the container 9. This can be done either by friction, or by a thread or by a bayonet lock.

The third embodiment in FIG. 5a provides a sleeve 12. This has a floor 13 and side windows 14 in the floor area. In the upper area, the sleeve 12 has locking ribs 15 to the full extent. The connection adapter 3 is also cylindrical. The basic spray device 2 is located in it. It is held at the top and bottom within this connection adapter 3 in the manner shown. The connection adapter 3 has a molded ring seal 11 in the lower circumferential area. In addition, it has locking elements corresponding to the locking ribs 15.

It works as follows:

First, the container 9 is inserted into the sleeve 12 from above in the form of an ampoule after the head of the ampoule has been broken off. Then the connection adapter 3 of the spray device 1 is plugged onto the sleeve 12 from above and moved downward until the ring seal 11 comes to rest sealingly on the shoulder of the container 9, in this position the locking ribs 15 of the sleeve 12 with corresponding locking elements of the Connection adapter 3 locked. By appropriate design of these locking ribs 15, the sleeve 12 and the connecting adapter 3 can be detachable or not.

The illustration in FIG. 5b shows a container 9 with a larger volume, so that the container 9 is higher in comparison to the container 9 of the embodiment in FIG. 5a. This container 9 is also inserted into the sleeve 12 and then the connection adapter 3 is pushed on from above. In this case, the connection adapter 3 does not protrude as far down as in the embodiment in FIG. 5a, since the shoulder of the container 9 is reached earlier.

As a container 9, not only ampoules are conceivable, but any type of container 9. The ring seal 11 can also engage in areas other than the shoulder on the container 9, namely outside on the jacket or inside in the area of the removal opening 10. LIST OF REFERENCE NUMBERS

1 spray device

2 basic spray device

3 connection adapters

4 bracket

5 bridge

6 clamping arm

7 riser pipe

8 spray head

9 container

10 removal opening

11 ring seal

12 sleeve

13 floor

14 windows

15 locking ribs

Claims

Expectations

1. Device for spraying liquids, the liquid being contained in a container (9) having a removal opening (10), with a spray device (1) which can be arranged on the removal opening (10) of the container (9), characterized in that the Container (9) a container (9), in particular ampoule, which is closed in one piece in its original state and has a breakable or sawable head to create the removal opening (10), is that the spray device (1) consists of a basic spray device (2) and a fixed one there is a connection adapter (3) arranged thereon for the container (9) and that the connection adapter (3) has an annular seal (11) which lies sealingly against the container (9).

2. Device according to the preceding claim, characterized in that the container (9) in the region of the removal opening (10) has a shoulder on which the ring seal (11) rests, and / or that the ring seal (11) on the outside of the container ( 9) rests in the casing area and / or that the ring seal (11) rests on the inside of the container (9) in the area of the removal opening (10).

3. Device according to one of the preceding claims, characterized in that the spray device (1) is a pump spray device.

4. Device according to one of the preceding claims, characterized in that a microfilter is assigned to the air inlet of the spray device (1).

5. Device according to one of the preceding claims, characterized in that the spray device (1) has an inside to about the bottom of the container (9) reaching riser pipe (7).

6. The device according to claim 5, characterized in that the riser pipe (7) is interchangeable or has predetermined breaking points for a reduction.

7. The device according to claim 5 or 6, characterized in that in the removal opening (10) of the container (9) a piercing plug made of an elastomeric material is arranged and that the riser pipe (7) has a piercing pin at its front end.

8. Device according to one of the preceding claims, characterized in that the spray device (1), in particular the riser pipe (7) is assigned a microfilter for the liquid.

9. Device according to one of claims 1 to 8, characterized in that a holder (4) for the container (9) by at least one in the longitudinal direction of the container (9) extending web (5) is formed, on which at least one Container (9) encompassing clamping arm (6) is arranged.

10. The device according to claim 9, characterized in that a pair of clamping arms (6) is designed like pliers.

11. The device according to claim 10, characterized in that the cross section of the clamping arm pair (6) is oval.

12. The device according to one of claims 1 to 8, characterized in that the spray device (1) can be fastened to the container (9) by means of frictional engagement or by means of a screw closure or a bayonet closure.

13. Device according to one of claims 1 to 8, characterized in that that the container (9) in a, at the lower end a bottom (13) having a sleeve (12) is received and that the sleeve (12) with its upper, open end is plugged or screwed onto the connecting adapter (3).

14. The apparatus according to claim 13, characterized in that the connection between the sleeve (12) and the connection adapter (3) is releasably latched, not releasably latched or is formed by a type of bayonet lock.

15. The apparatus according to claim 13 or 14, characterized in that the connecting adapter (3) is substantially cylindrical and has the ring seal (11) at its lower peripheral end.

16. Device according to one of the preceding claims, characterized in that on the spray device (1) a spray head (8) can be interchangeably arranged.